Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
NCT01146782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 367
Last updated 2014-06-30
Summary
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA marketing clearance of the device.
Conditions
Interventions
- DEVICE
-
Attune Sleep Apnea System
Console and mouthpiece sleep apnea system
Sponsors & Collaborators
-
ApniCure, Inc.
lead INDUSTRY
Principal Investigators
-
Ian Colrain, PhD · Stanford Reasearch Institute (SRI)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2012-03-31
- Completion
- 2012-03-31
Countries
- United States
Study Locations
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